| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00068-1 |
| Product Name/Description |
Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System Kit
All lot numbers affected
Product Codes: 283910000 and 283913000 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
The cement mixer used to prepare cement for surgery has been identified to not turn properly. The event may be described as the mixer being 'jammed' or 'stuck' and not able to turn, which could result in surgical delay in order to prepare another kit, or the inability to complete the procedure if an additional kit is not available; thereby exposing the patient to additional anaesthesia in another surgical procedure. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are being advised to quarantine any affected products and return the products for a credit. |
| Contact Information |
1300 562 711 - Johnson & Johnson Medical Customer Service |